The Independent Data Monitoring Committee of the Phase III OVATURE trial has recommended that the study continue. The multicenter international study is testing US drug developer Marshall Edwards' orally-administered investigational drug phenoxodiol in combination with carboplatin in advanced ovarian cancer which resistant or refractory to platinum-based drugs.
The Committee recommended that the study remain open and continue as planned towards its accrual target of 340 patients. "We are pleased to report that, at the time of the Committee meeting, 78 patients had completed the study, and a substantial data set was made available for review. While site recruitment was slower than expected in the early stages of the study, we now have 75 sites involved and the pace of recruitment has increased significantly. We will continue to apply all possible strategies to ensure the study continues towards its interim and final analysis endpoints," said group director of research, Alan Husband.
The OVATURE trial is recruiting ovarian cancer patients whose disease initially responded to chemotherapy, but has since become resistant or refractory to traditional platinum treatments. Participants are being recruited at sites across the USA, the UK, Europe and Australia. Currently, 75 centers are participating in the evaluation.
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